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Insignia 136-0242Recalls & reported problems

Alphatec Spine, Inc. · Insignia, ACP, 2 Level, 42 mm · Class 2 · Implant

All models of Insignia (34)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376268415), received between Apr 16, 2021 and Apr 16, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

29 other recalls cover devices cleared under the same FDA submission (K200995); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Break1

Patient problems

  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 16, 2021Break; Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO REMOVE AND REPLACE AN INSIGNIA 2 LEVEL PLATE. POST-OP IMAGES TAKEN 6 WEEKS AFTER INITIAL SURGERY REVEALED A SCREW BLOCKING MECHANISM DISASSEMBLED FROM THE PLATE. THE INSIGNIA 2 LEVEL PLATE WAS IMPLANTED ON (B)(6) 2020.

    Patient problems: Failure of Implant

    MAUDE report 11682725 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200995. One submission often covers many models, so check the product and lot details in each record.

  • Z-1811-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
  • Z-1810-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392
  • Z-1826-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705
  • Z-1806-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
  • Z-1817-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
  • Z-1805-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
  • Z-1803-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
  • Z-1818-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
  • Z-1800-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
  • Z-1809-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
  • Z-1823-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
  • Z-1824-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
  • Z-1808-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378
  • Z-1813-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
  • Z-1827-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712

…and 14 more.

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Sources and updates

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